Introduction:
Behold the “Modernization of Cosmetic Regulation Act of 2022” that President Biden signed on December 29, 2022. This law requires an increased FDA oversight of cosmetics and their ingredients. In this article, we’ll discuss the key provisions, timelines for enforcement actions, and new requirements and summarize the regulatory implementation mentioned in this Act. This new U.S. law includes amendments to FDA requirements around improvements in drug manufacturing and reauthorization of essential FDA programs. We wouldn’t be surprised if Amazon started taking a more proactive approach to this law, even with a 3-year timeline before MoCRA goes into full effect.
What was the voluntary process of registering cosmetic products before MoCRA?
Registering a cosmetic product with the U.S. Food and Drug Administration (FDA) is a voluntary process, as cosmetics are not subject to pre-market approval by the FDA. However, the FDA does require cosmetic manufacturers, packers, and distributors to comply with specific labeling, safety, and manufacturing regulations. Here’s an overview of the steps involved in registering a cosmetic product:
1. Determine If Your Product Is a Cosmetic:
- The FDA defines cosmetics as products intended to cleanse, beautify, promote attractiveness, or alter appearance without affecting the body’s structure or functions. Ensure that your product falls within the FDA’s definition of a cosmetic.
2. Understand Cosmetic Regulations:
- Familiarize yourself with FDA regulations pertaining to cosmetics. These regulations cover aspects such as labeling, ingredient safety, and good manufacturing practices (GMP).
3. Conduct Ingredient Safety Assessments:
- Cosmetic manufacturers are responsible for ensuring the safety of their products and their ingredients. Conduct safety assessments of the ingredients you intend to use in your cosmetic product. This may involve reviewing existing safety data, conducting tests, or consulting with toxicologists.
4. Prepare and Label the Product:
- Design the product label, ensuring compliance with FDA labeling regulations. Include required information, such as the product’s identity, net quantity of contents, ingredient list, manufacturer’s name and address, and any necessary warnings or directions.
5. Establish and Implement GMP:
- While cosmetic manufacturers are not required to follow GMP regulations like pharmaceutical manufacturers, it’s advisable to implement good manufacturing practices to ensure the quality and safety of your products.
6. Report Adverse Events:
- Manufacturers and distributors of cosmetics are encouraged to report any adverse events related to their products to the FDA’s Voluntary Cosmetic Registration Program (VCRP). This helps the FDA monitor product safety and identify potential issues.
7. Register Cosmetic Establishment (Optional):
- While cosmetic product registration is not mandatory, you can voluntarily register your cosmetic establishment and products through the FDA’s Voluntary Cosmetic Registration Program (VCRP). This involves providing information about your company and products. Registration is often a way to demonstrate compliance with FDA regulations.
What is the Modernization of Cosmetic Regulation Act of 2022 (MoCRA)
MoCRA will establish a process to ensure cosmetic manufacturers provide assurances that their products are safe for consumer use. The law puts together responsibilities for the “responsible person,” the packer, creator, or distributor of the cosmetic whose name appears on the cosmetic label. MoCRA applies to importers and entities who manufacture or process cosmetics.
It does not apply to the following entities if they do not import, manufacture, or process cosmetics: beauty salons; cosmetic product retailers; distribution facilities; pharmacies; hospitals; physicians’ offices; health care clinics; public health agencies and other nonprofit entities; entities that provide complimentary cosmetic products; trade shows and others giving free samples; entities that are only doing research; and entities that prepare labels, relabel, package, repackage, hold, or distribute cosmetic products.
Good Manufacturing Practices: The secretary of the Department of Health and Human Services (HHS) (through the FDA) will propose and finalize regulations to establish good manufacturing practices. The key is ensuring that products are not adulterated and allowing the FDA to inspect records to ensure compliance. The proposed rulemaking shall be no later than two years after the date of enactment (December 29, 2022), with final regulations no later than three years after the date of enactment (December 29, 2022).
Process for reporting adverse events: In compliance with the HHS secretary’s regulations, the responsible person shall file a report within 15 days and may supplement the account within one year. A serious adverse event report is similar to other safety reports. It can include a statement released to the public (without personal health information). The HHS secretary may exempt specific accounts that do not involve a significant public health issue. The responsible person must keep records for six to three years for small businesses. There is a Rule of Construction that submitting any report shall not be construed as an admission that the cosmetic product involved, caused, or contributed to the relevant adverse event.
MoCRA Registration and product listing:
Cosmetic manufacturers must submit a registration one year after enactment (December 29, 2022). New facilities must register within 60 days (or 60 days after the deadline). Renewal is every two years. Updates or changes must be submitted within 60 days of the change. The company registering its cosmetic products must list everything they import, manufacture, or process, including product categories, ingredients, and a product listing number. Flexibility may be given to listing multiple products with identical formulations, colors, fragrances, quantities, or flavors. The FDA will not share confidential information in a listing when filing an information request.
Cosmetic Entity Registration:
The HHS secretary may suspend registration if there is a potential for the product to cause severe adverse health effects or deaths. The HHS secretary will send a notice of suspension if health concerns arise after the manufacturing of the health products and may conclude that:
- the rest remains necessary or
- the registrant must submit a corrective action plan to demonstrate remediation of the problem conditions.
Within 14 business days, the plan will be reviewed. If the secretary vacates the suspension, the FDA will restart the registration. If the cosmetic manufacturing facility is suspended, nobody will be allowed to introduce or deliver cosmetic products from the suspended facility.
Records must be made available to authorized personnel for product examination if there is reason to believe a cosmetic product is adulterated or an ingredient may cause harm or violate other standards. Authorized personnel must provide written notice to gain access to records in a reasonable amount of time to determine whether the product poses a threat. Recipes or formulas for cosmetics, financial data, pricing data, personnel data (except qualifications), research data (other than safety substantiation), or sales data are not among the records to be reviewed (other than shipment data regarding sales).
